Delivery systems for stents having protruding features

ABSTRACT

Delivery systems for expandable elements, such as stents or scaffolds having spikes, flails, or other protruding features for penetrating target tissue and/or delivering drugs within a human patient are described along with associated methods for using such systems. The delivery systems can be provided with a stent that is positioned over an inflatable balloon for expansion and delivery of the stent to a target delivery location. By positioning the stent over and about the inflatable balloon, the stent is ready to be expanded by the balloon immediately upon unsheathing with respect to the outer shaft. Additionally or alternatively, a stent can be positioned in an axially offset arrangement with respect to a balloon to reduce the need for space required by overlapping components.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/742,852, entitled “DELIVERY SYSTEMS FOR STENTS HAVING PROTRUDINGFEATURES,” filed Oct. 8, 2018, the entirety of which is incorporatedherein by reference.

TECHNICAL FIELD

The present description relates generally to delivery systems forexpandable elements, such as stents or scaffolds having spikes, flails,or other protruding features for penetrating target tissue and/ordelivering drugs within a human patient.

BACKGROUND

A variety of devices can be used to deliver drugs at desired treatmentlocations within a patient. For example, a stent, such as a drug-elutingstent (DES), can be positioned at the location of a stenosis (arterialnarrowing) caused by arteriosclerosis. DESs generally include a drugcontaining polymer coated over a metal stent or scaffold, or abioresorbable stent or scaffold composed of a drug-containing polymer.After a DES is delivered to a treatment location within a body lumen(e.g., vessel), it is expanded against a wall of the body lumen (e.g., avessel wall) and the drug is released via direct contact with the wall.Direct delivery of the drug to the vessel wall enables significantlylower doses than those required via other delivery means (e.g., pills orinjections).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a partially schematic side view of an example of a deliverysystem.

FIG. 2 shows a cross-sectional view of an example region of the deliverysystem of FIG. 1 taken along line 2-2.

FIG. 3 shows an enlarged, partially schematic side view of a distalportion of the delivery system of FIG. 1 with an unconstrained stent.

FIG. 4 shows a perspective view of an example of a stent.

FIG. 5 shows a side view of the stent of FIG. 4.

FIG. 6 shows a front view of the stent of FIG. 4.

FIG. 7 shows a perspective view of an example of a connector end of thestent of FIG. 4.

FIG. 8 shows a perspective view of another example of a connector end ofthe stent of FIG. 4.

FIG. 9 shows a perspective view of another example of a connector end ofthe stent of FIG. 4.

FIG. 10 shows a perspective view of another example of a connector endof the stent of FIG. 4.

FIG. 11 shows a side view of an example of a delivery system in a firststage of deployment.

FIG. 12 shows a side view of the delivery system of FIG. 11 in a secondstage of deployment.

FIG. 13 shows a side view of the delivery system of FIG. 11 in a thirdstage of deployment.

FIG. 14 shows a side view of the delivery system of FIG. 11 in a fourthstage of deployment.

FIG. 15 shows a cross-sectional view of an example region of a deliverysystem.

FIG. 16 shows a side view of another example of a delivery system in afirst stage of deployment.

FIG. 17 shows a side view of the delivery system of FIG. 16 in a secondstage of deployment.

FIG. 18 shows a side view of the delivery system of FIG. 16 in a thirdstage of deployment.

FIG. 19 shows a side view of the delivery system of FIG. 16 in a fourthstage of deployment.

FIG. 20 shows a side view of the delivery system of FIG. 16 in a fifthstage of deployment.

FIG. 21 shows a side view of another example of a delivery system in afirst stage of deployment.

FIG. 22 shows a side view of the delivery system of FIG. 21 in a secondstage of deployment.

FIG. 23 shows a side view of the delivery system of FIG. 21 in a thirdstage of deployment.

FIG. 24 shows a side view of the delivery system of FIG. 21 in a fourthstage of deployment.

FIG. 25 shows a side view of an example of a delivery system in a firststage of deployment.

FIG. 26 shows a side view of the delivery system of FIG. 25 in a secondstage of deployment.

FIG. 27 shows a side view of the delivery system of FIG. 25 in a thirdstage of deployment.

FIG. 28 shows a side view of the delivery system of FIG. 25 in a fourthstage of deployment.

FIG. 29 shows a side view of an example of a delivery system in thedelivery state within a body lumen.

FIG. 30 shows a cross-sectional view of the delivery system of FIG. 29in a deployed state.

FIG. 31 shows a cross-sectional view of the delivery system of FIG. 29with a balloon and a stent in an expanded state within a body lumen.

FIG. 32 shows a cross-sectional view of a region of the delivery systemof FIG. 29 with a stent in a treatment state and a balloon in acollapsed state that allows for fluid flow.

In one or more implementations, not all of the depicted components ineach figure may be required, and one or more implementations may includeadditional components not shown in a figure. Variations in thearrangement and type of the components may be made without departingfrom the scope of the subject disclosure. Additional components,different components, or fewer components may be utilized within thescope of the subject disclosure.

DETAILED DESCRIPTION

The detailed description set forth below is intended as a description ofvarious implementations and is not intended to represent the onlyimplementations in which the subject technology may be practiced. Asthose skilled in the art would realize, the described implementationsmay be modified in various different ways, all without departing fromthe scope of the present disclosure. Accordingly, the drawings anddescription are to be regarded as illustrative in nature and notrestrictive.

The following disclosure describes various embodiments of deliverysystems for expandable structures, such as stents or scaffolds, havingspikes, flails, or other protruding features for penetrating targettissue and/or delivering drugs within a human patient, and associateddevices and methods. The delivery systems can be configured to deliverand position expandable structures within a body lumen (e.g., vessel).In addition, these delivery systems can also be configured to deploy andexpand the expandable structures in the body lumen. The delivery systemscan further be configured to engage with the expanded structure andcollapse the structure for removal from the body lumen. In someembodiments, the delivery systems can be configured to deliver anotherexpandable structure or the same expandable structure to another bodylumen, or the same body lumen, in a single procedure or during aplurality of procedures. Such delivery systems are expected to simplifyand expedite transluminal procedures to more effectively deliver andposition expandable structures within target tissues. The deliverysystems can be used with more than one procedure, such as deployment ofan expandable structure, when configured to recapture the deployedexpandable structure.

In particular, delivery systems described herein can be provided with astent that is positioned over an inflatable balloon for expansion anddelivery of the stent to a target delivery location. By positioning thestent over and about the inflatable balloon, the stent is ready to beexpanded by the balloon immediately upon unsheathing with respect to theouter shaft. Additionally or alternatively, a stent can be positioned inan axially offset arrangement with respect to a balloon to reduce theneed for space required by overlapping components.

Certain details are set forth in the following description and FIGS.1-32 to provide a thorough understanding of various embodiments of thedisclosure. To avoid unnecessarily obscuring the description of thevarious embodiments of the disclosure, other details describingwell-known structures and systems often associated with expandablestructures, protruding features, and the components or devicesassociated with the manufacture of such structures are not set forthbelow. Moreover, many of the details and features shown in the figuresare merely illustrative of particular embodiments of the disclosure.Accordingly, other embodiments can have other details and featureswithout departing from the spirit and scope of the present disclosure. Aperson of ordinary skill in the relevant art will therefore understandthat the present technology, which includes associated devices, systems,and procedures, may include other embodiments with additional elementsor steps, and/or may include other embodiments without several of thefeatures or steps shown and described below with reference to FIGS.1-32. Furthermore, various embodiments of the disclosure can includestructures other than those illustrated in the figures and are expresslynot limited to the structures shown in the figures.

FIG. 1 shows a partially schematic side view of a delivery system 100for a stent in a delivery state (e.g., low-profile or collapsedconfiguration). The delivery system 100 includes an outer shaft 120(e.g., a catheter) having one or more lumens for containing an innershaft 110 and/or a guidewire 162. In some embodiments, the outer shaft120 may also include one or more layers. In these embodiments, forexample, the layers of the outer shaft 120 can include an inner layer,an outer layer, a liner, or a combination thereof. Each of the layerscan be formed from materials including a polymer, high-densitypolyethylene (HDPE), polytetrafluoroethylene, silicone, Pebax®(polyether block amide) or a combination thereof. In some embodiments,each of the layers of the outer shaft 120 are formed from the samematerial. In other embodiments, however, one or more of the layers maybe formed from different materials.

The inner shaft 110 can extend from a connector 150, through the outershaft 120, and beyond the distal portion 120 b of the outer shaft 120.The inner shaft 110 can be formed as a tubular structure (with orwithout a slit), such as a coiled tube, a braided tube, a reinforcedtube, or a combination thereof, and may be constructed of a polymermaterial, such as a polyimide. The delivery system 100 can include aguidewire within the inner shaft 110 and accessible at a proximal end ofthe delivery system 100.

In the detailed view of the distal portion 100 b of the delivery system100, a tip 115 (e.g., an atraumatic tip) is disposed on a distalterminal end of the inner shaft 110. As illustrated, the tip 115 isadjacent to a distal terminal end of the outer shaft 120. At least aportion of the tip 115 can have the same cross-sectional dimension asthe outer shaft 120, or the tip 115 may have a different cross-sectionaldimension. In some embodiments, a distal end 115 b of the tip 115 istapered such that the distal end 115 b has a smaller cross-sectionaldimension compared to a proximal end 115 a of the tip. Distal and/orproximal edges of the tip 115 may be curved/rounded so as to prevent thetip 115 from getting caught (e.g., stuck) on other portions of thedelivery system 100 during delivery, positioning, deployment, etc. Thetip 115 can be formed of the same material(s) as the outer shaft 120. Inother embodiments, however, the tip 115 can be formed from differentmaterial(s) than the outer shaft 120.

The inner shaft 110 and the outer shaft 120 can be sized and shaped forintravascularly accessing a target site (e.g., treatment site) of thepatient. In some embodiments, for example, the outer shaft 110 has alength of about 150 cm to about 180 cm and a suitable cross-sectionaldimension for positioning within a subject's vasculature. The length ofthe inner shaft 110 can be a working length, such as a length that canbe positioned within a subject's vasculature. In some embodiments, forexample, the working length is about 70 cm to about 300 cm, about 150 cmto about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm,about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm,about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm,about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm,about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm.In other embodiments, the outer shaft 120 has a length of about 130centimeters (cm) to about 140 cm and a cross-sectional dimension ofabout 4 French, about 5 French, or about 6 French. The length of theouter shaft 120 can be a working length, such as a length that can bepositioned within a subject's vasculature. In some embodiments, theworking length is about 50 cm to about 200 cm, about 100 cm to about 150cm, or about 50 cm, about 60 cm, about 70 cm, about 80 cm, about 90 cm,about 100 cm, about 110 cm, about 120 cm, about 125 cm, about 130 cm,about 135 cm, about 140 cm, about 145 cm, about 150 cm, about 155 cm,about 160 cm, about 170 cm, about 180 cm, about 190 cm, or about 200 cm.

In the detailed view of the proximal portion 100 a of the deliverysystem 100 in FIG. 1, a proximal end 120 c of the outer shaft is coupledto an outer shaft hub 140. In the illustrated embodiment, the outershaft hub 140 is coupled to the outer shaft 120 (e.g., via bonding). Inother embodiments, however, the proximal end 120 c of the outer shaft isdirectly coupled to the outer shaft hub 140.

The outer shaft hub 140 is further coupled to a connector 150 (e.g.,y-connector) having a lumen extending therethrough (not shown). Inparticular, a distal end 150 b of the connector 150 can be coupled tothe outer shaft hub 140 via a mating feature and a receiving feature(not shown). The mating and receiving features can be coupled to theproximal portion of the outer shaft 120 or the distal end 150 b of theconnector 150. The connector 150 further includes a port 152 extendingradially and/or longitudinally therefrom. The delivery system 100 canoptionally include a hemostasis connector 170 coupled to a proximal end150 a of the y-connector 150. While the proximal end 120 c isillustrated with particular components in a particular arrangement, itwill be understood that additional or fewer components can be includedin similar or other arrangements to meet the needs of the system.

The delivery system 100 is configured to carry a stent, discussedfurther herein, in a delivery/collapsed state within a distal portion ofthe outer shaft 120. The stent can be at least partially ensheathed bythe outer shaft 120. In some embodiments, the stent can be fixedly orremovably coupled to the inner shaft 110. Although the delivery system100 is illustrated as a delivery system for stents, it will beappreciated that embodiments of the present technology can also includecages, meshes, balloons, membranes, tubular structures, circumferentialbodies, expandable elements, expandable membranes, expandablestructures, expandable tubular structures, and circumferentiallyexpandable catheter tips with and without guidewire lumens.

FIG. 2 shows a cross-sectional view of a region of the delivery system100 of FIG. 1 taken along line 2-2. As illustrated in FIG. 2, the innershaft 110 can be at least partially disposed within a lumen of the outershaft 120 and the guidewire 162 can be at least partially disposedwithin a lumen of the inner shaft 110. In some embodiments, the outershaft 120, the inner shaft 110, and/or the guidewire 162 each have acircular cross-sectional shape. In other embodiments, however, the outershaft 120, the inner shaft 110, and/or the guidewire 162 can have othercross-sectional shapes, such as an ovoid shape, a “C” shape, arectangular shape, a triangular shape, or the like.

The guidewire 162 and the inner shaft 110 can be positioned within thelumen of the outer shaft 120 in any configuration, such as anteriorlyand posteriorly as illustrated, or medially and laterally. Furthermore,the guidewire 162 and the inner shaft 110 can be positioned in the lumenof the outer shaft 120 with respect to one another as illustrated, orthe guidewire 162 can be positioned outside the inner shaft 110. A fluidpathway can be defined within the lumen of the inner shaft 110, forexample along the length of the guidewire 162. The fluid pathway canconnect to and/or be accessible by the port 152 of the connector 150.

FIG. 3 shows a side view of a distal portion 100 b of the deliverysystem 100 of FIG. 1 in a deployed state. In the illustrated embodiment,a stent 190 extends over a balloon 180 and is coupled to the deliverycatheter shaft and has been unsheathed from the distal portion 120 b ofthe outer shaft. A proximal visualization marker 192 is disposed on thestabilizing wire 160 near a proximal portion of the stent 190 and distalvisualization markers 197 are disposed on a distal end 190 c of thestent. In some embodiments, the proximal visualization marker 192 and/orthe distal visualization marker 197 may be disposed on the stabilizingwire 160. The visualization markers 192 and/or 197 can be formed fromany material that can be visualized while the stent 190 isintravascularly positioned (e.g., within a target blood vessel). In oneembodiment, for example, the visualization markers 192 and/or 197 areradiopaque markers. The stabilizing wire 160 can be connected to theinner shaft 110, such that movement of the inner shaft 110correspondingly urges the stent 190 via the stabilizing wire 160, asdiscussed further herein. Alternatively, the stabilizing wire 160 can beindependently movable relative to the inner shaft 110, as discussedfurther herein.

The tip 115 is disposed on a terminal end 110 c of the inner shaft 110and can surround the terminal end 110 c extending proximally along thedistal portion 110 b and/or distally from the terminal end 110 c. Theinner shaft 110 extends distally from the distal portion 120 b of theouter shaft 120, through a lumen of the stent 190, and, optionally,extends distally from the distal end of the stent 190. In the deployedconfiguration, protruding features 194 extend radially from alongitudinal axis of the stent 190, as discussed further herein.

The inner shaft 110 can also include an inflatable balloon (not shown),as discussed further herein. The inflatable balloon can be axiallyoverlapping with the stent 190, distal to the stent 190, or proximal tothe stent 190 while the stent 190 is in a delivery state (e.g.,low-profile or collapsed configuration) within the outer shaft 120and/or while the stent 190 is initially deployed from the deliverystate.

The guidewire 162 can extend through the inner shaft 110 and beyond thetip 115. Accordingly, the guidewire 162 can be advanced ahead of otherportions of the delivery system 100. The inner shaft 110, the stent 190,and the outer shaft 120 can be advanced over the guidewire 162 until thestent 190 is aligned with a desired target delivery location. The lengthof the guidewire 162 that overlaps other portions of the delivery system100 can be within the inner shaft 110, so that it does not interferewith any other components of the delivery system 100.

As shown in FIGS. 4-6, the expandable stent 190 is provided with a frame191 and multiple protruding features 194. The frame 191 and theprotruding features 194 can be configured to radially expand after thestent 190 has been unsheathed from the outer shaft 120. The stent 190can be self-expanding upon release from a constraint. Additionally oralternatively, the stent 190 can be expandable by radial forces appliedfrom a balloon that is inflated while within the stent 190. The frame191 can include multiple struts 195 arranged in a pattern that supportscompression, expansion, flexibility, and bendability of the stent 190.The frame 191 can form a generally cylindrical shape along at least aportion of the stent 190. At least a portion of each protruding feature194 can extend at least partially distally from the frame 191 (e.g.,towards the distal end 190 c). For example, at least a portion of eachprotruding feature 194 can extend parallel to a longitudinal axis of thestent 190. At least a portion (e.g., terminal end portion) of eachprotruding feature 194 can extend at least partially radially away fromthe frame 191. For example, at least a portion of each protrudingfeature 194 can extend radially outwardly (e.g., perpendicular to) thelongitudinal axis of the stent 190. With at least a portion of eachprotruding feature 194 extending distally from the frame 191, theprotruding features 194 can be readily retracted into the outer shaft120 by folding down and extending distally when the outer shaft 120 isadvanced from a proximal side of the stent 190 in a distal directionover the stent 190. The protruding features 194 can optionally includedrugs for delivery to a target delivery location upon expansion of thestent 190. However, it will be understood that a stent 190 can omitdrugs for delivery and treat a target delivery location by penetratingtissue with the protruding features 194.

The frame 191, struts 195, and/or protruding features 194 can becomposed of or formed from a variety materials including, e.g., nitinol,cobalt chromium, stainless steel, any of a variety of other metals ormetal alloys, or a combination thereof. The frame 191, struts 195,and/or protruding features 194 may also be composed of or formed frombioresorbable biodegradable, nanoporous or non-bioresorbable,non-biodegradable, non-nanopourous materials including, e.g., one ormore polymers, nitinol, plastic materials, etc., or a combinationthereof. In some embodiments, the frame 191 and the struts 195 can beformed from a bioresorbable material and the protruding features 194 canbe formed from a non-bioresorbable material, such as nitinol. In theseembodiments, the protruding features 194 can remain engaged with orpenetrating a portion of the body lumen after the expanded frame 191 andstruts 195 bio-resorb. After the expanded frame 191 and struts 195bio-resorb, the body lumen where the stent 190 had been expanded is nolonger partially occluded by the frame 191 and the struts 195 allowingfor larger volumes of fluids, such as aqueous pharmaceuticalcompositions, to pass through the body lumen and contact the luminalwall. The protruding features 194 may also be formed of a bio-resorbablematerial and, once the stent 190 has bio-resorbed, the spaces in thebody lumen wall vacated by the protruding features 194 can be contactedby the fluids passing through the body lumen. In this way, the stent 190can increase a surface area of the body lumen wall contacted by thefluid.

The protruding features 194 may also be carried by more than one strut195, the frame 191, or a combination thereof. The protruding features194 may be integrally formed with the struts 195, for example by bendingor twisting a portion of one or more struts and/or the frame 191 awayfrom a longitudinal axis of the stent 190 or, alternatively, theprotruding features 194 may be separate, discrete components that areattached to desired locations along the struts 195 and/or the frame 191.

The stent 190 can include an anchor portion 196 that securely connectsto a component for controlling, positioning, and/or adjusting the stent190. For example, the anchor portion 196 can securely connect the stent190 to the inner shaft 110. Alternatively, the anchor portion 196 cansecurely connect the stent 190 to the stabilizing wire 160. The anchorportion 196 can be offset from a central axis of the stent 190. Forexample, the anchor portion 196 can be radially aligned with, adjacentto, or near a portion of the frame 191 of the stent 190. The frame 191of the stent 190 can be connected to the anchor portion 196 by anintermediate portion 193. The intermediate portion 193 can includemultiple struts that may have varying widths to aide in column strengthfor deploying and retraction that extend from different portions of theframe 191, for example connecting to different circumferential portionsat an end of the frame 191. The struts of the intermediate portion 193can extend to the same or different axial locations along the anchorportion 196. The arrangement of the struts of the intermediate portion193 can maintain an open central space along the entire length of thestent 190.

As shown in FIGS. 7-10, the anchor portion 196 can be formed with one ormore of a variety of arrangements. As shown in FIG. 7, the anchorportion 196 can include multiple ribs 902 extending circumferentiallyfrom different axial locations along the anchor portion 196. The ribs902 can be positioned at different axial locations to provide multiplepoints of contact with a positioner, such as the inner shaft 110 and/orthe stabilizing wire 160.

As shown in FIG. 8, the anchor portion 196 can include differentportions that extend in different directions. For example, the anchorportion 196 can include longitudinal portions 904 and circumferentialportions 906. Axially adjacent pairs of the longitudinal portions 904can be connected together by a corresponding circumferential portion906. Likewise, axially adjacent pairs of the circumferential portions906 can be connected together by a corresponding longitudinal portion904. Different longitudinal portions 904 can have differentcircumferential positions to surround a coupled positioned at differentcircumferential positions thereon.

As shown in FIG. 9, the anchor portion 196 can include a helical winding908. For example, the anchor portion 196 can wind helically about acentral space configured to receive the positioner therein. The helicalwinding 908 can include multiple (e.g., 2, 3, 4, 5, 6, 7, 8, or morethan 8) turns. The helical winding 908 can include, in cross-section, ashape that provides a flat inner side for engaging the positioner whilemaintaining a low profile.

As shown in FIG. 10, the anchor portion 196 can include an arrangementof multiple struts 910. The struts 910 can define a generallycylindrical shape for receiving and coupling to a positioner. The struts910 can extend longitudinally and/or circumferentially about the spacefor receiving the positioner. The struts 910 can form any number ofcells, which can vary in length and/or width relative to each other.

The anchor portion 196 can securely connect the stent 190 to apositioner, such as the inner shaft 110 and/or the stabilizing wire 160.For example, the anchor portion 196 can be pressed onto the positioner.By further example, the anchor portion 196 can be bonded to thepositioner. Additionally or alternatively, a sleeve can be providedabout at least a portion of the anchor portion 196 and/or thepositioner. For example, a tube, such as shrink tubing molded from oneor more flexible materials, including polyurethane and Pebex® (e.g.,Pebex® 35D), can be provided as a sleeve over the anchor portion 196and/or the positioner. Additionally or alternatively, the stabilizingwire 160 can be connected to the inner shaft 110 by one or more of avariety of methods, including laser welding, bonding, crimping, swaging,reflowing, etc. Additionally or alternatively, the anchor portion 196can removably or reversibly connect the stent 190 to a positioner. Forexample, the anchor portion 196 can be provided with one or moredetachment mechanisms (e.g., electrolytic, mechanical, or chemical) forcontrollably separating the stent 190 from the positioner. As such, thestent 190 can be controllably detached and left at a target deliverylocation.

Methods described herein provide delivery of the stent 190 to a targetdelivery location by operation of the delivery system 100. While methodsin their various stages are discussed and illustrated herein, it will beunderstood that multiple variations of each method are alsocontemplated. For example, the methods can be performed in variousorders of operations, with additional operations, or with feweroperations.

As shown in FIGS. 11-14, a delivery system 100 can be provided with astent 190 that is positioned over an inflatable balloon 180 forexpansion and delivery of the stent 190 to a target delivery location.By positioning the stent 190 over and about the inflatable balloon 180,the stent 190 is ready to be expanded by the balloon 180 immediatelyupon unsheathing with respect to the outer shaft 120.

As shown in FIG. 11, the delivery system 100 is provided with the outershaft 120 covering or ensheathing other components of the deliverysystem 100. For example, the outer shaft 120 can extend to the tip 115positioned at a distal end of the inner shaft 110. The inner shaft 110can extend within the outer shaft 120, with a length thereof accessibleproximal to a proximal end of the outer shaft 120 (e.g., at the outershaft hub 140). Additionally or alternatively, the connector 150 can beaccessible proximal to a proximal end of the outer shaft 120 (e.g., atthe outer shaft hub 140). As discussed above, a guidewire can beadvanced ahead of the tip 115 (e.g., through the inner shaft 110) toprovide a pathway for advancement of other components of the deliverysystem 100.

As shown in FIGS. 12 and 13, the outer shaft 120 can be moved tounsheath the stent 190 and other components of the delivery system 100.For example, once the distal region of the delivery system 100 ispositioned at a desired location, the outer shaft 120 is configured tobe at least partially proximally retracted relative to the inner shaft110 by retracting the outer shaft hub 140 relative to the connector 150.Once the outer shaft 120 is partially retracted, at least a portion ofthe stent 190 and/or the balloon 180 is unsheathed and protrudingfeatures 194 of the stent 190 are configured to radially expandoutwardly away from the inner shaft 110.

As used herein, movement of various components can be relative to othercomponents of the delivery system 100 and/or relative to a positionapart from the delivery system 100 (e.g., a position within the anatomyof the patient, target delivery location, and/or tissue). The directions“proximal” and “distal” can be with respect to the delivery system 100,a component thereof, and/or a position apart from the delivery system100. For example, movement of the guidewire 162 can be relative to theouter shaft 120, the inner shaft 110, the stent 190, and/or the balloon180. It will be understood that while the guidewire 162 moves, the outershaft 120, the inner shaft 110, the stent 190, and/or the balloon 180can be stationary, moving in the same direction (e.g., at a differentspeed), or moving in a different (e.g., opposite) direction. It will befurther understood that while the outer shaft 120, the inner shaft 110,the stent 190, and/or the balloon 180 moves, the guidewire 162 can bestationary, moving in the same direction (e.g., at a different speed),or moving in a different (e.g., opposite) direction. By further example,movement of the outer shaft 120 can be relative to the inner shaft 110,the stent 190, and/or the balloon 180. It will be understood that whilethe outer shaft 120 moves, the inner shaft 110, the stent 190, and/orthe balloon 180 can be stationary, moving in the same direction (e.g.,at a different speed), or moving in a different (e.g., opposite)direction. By further example, movement of the inner shaft 110, thestent 190, and/or the balloon 180 can be relative to outer shaft 120. Itwill be understood that while the inner shaft 110, the stent 190, and/orthe balloon 180 move, the outer shaft 120 can be stationary, moving inthe same direction (e.g., at a different speed), or moving in adifferent (e.g., opposite) direction.

As shown in FIG. 14, the outer shaft 120 has been retracted and thestent 190 is unsheathed. The stabilizing wire 160, connected to theinner shaft 110 by the anchor portion 196, is configured to engage withthe proximal end of the stent 190 and control the position of the stent190 during and after retraction of the outer shaft 120. Accordingly, theposition of the stent 190 is maintained with respect to the inner shaft110, including the balloon 180. For example, while some adjustment ofthe length and/or axial position of the stent 190 may occur duringradial expansion of the stent 190, it will be understood that thestabilizing wire 160 can maintain the position of at least a portion ofthe stent 190 to be around and axially aligned with at least a portionof the balloon 180. The balloon 180 can have an axial length that isgreater than the axial length of the stent 190, so that an entirety ofthe stent 190 is overlapping with the balloon 180. As shown in FIG. 14,the stabilizing wire 160 can connect the stent 190 to a portion of theinner shaft 110 that is proximal to the balloon 180. Additionally oralternatively, the stabilizing wire 160 can connect the stent 190 to aportion of the inner shaft 110 that is distal to the balloon 180.

When both the stent 190 and the balloon 180 are unsheathed by the outershaft 120 and exposed, the balloon 180 can be inflated to expand orfurther expand the stent 190. For example, an interior region of theballoon can be fluidly connected, via the inner shaft 110, to the port152 of the connector 150. By providing a fluid through the port 152, theballoon 180 can be expanded, thereby expanding or further expanding thestent 190. The expansion with respect to target anatomy will be furtherdiscussed herein.

Following one or more of the above-described operations, the balloon 180can be deflated. The stent 190 can be maintained for any duration oftime in an expanded state. For example, the stent 190 can be maintainedfor a duration of time effective to provide therapeutic treatment (e.g.,remodeling and/or drug delivery) to target anatomy and allows fluid flowthrough the expanded stent and deflated balloon where there is no fluidblockage through the treated site.

Additionally or alternatively, the delivery system 100 can be deployedat multiple locations. The stent 190 can be collapsed by moving theouter shaft 120 over the stent 190. The stent 190 and the balloon 180can be moved to another target location, and one or more of theabove-described operations can be repeated.

Additionally or alternatively, the delivery system 100 can be removed.The stent 190 can be collapsed by moving the outer shaft 120 over thestent 190. Components of the delivery system 100 can be removed from thepatient by retracting proximally over the guidewire.

Additionally or alternatively, the stent 190 can be detached from theinner shaft 110 and left as an implant within the patient. Followingdetachment, other components of the delivery system 100 can be removedfrom the patient by retracting proximally over the guidewire.

While the delivery system 100 is shown with a stent 190 positioned overa balloon 180 in a delivery state, it will be understood that otherarrangements are contemplated. For example, a stent can be positioned inan axially offset arrangement with respect to a balloon to reduce theneed for space required by overlapping components. Reference is made toa delivery system 200, as shown in FIGS. 16-20, a delivery system 300,as shown in FIGS. 21-24, and a delivery system 500, as shown in FIGS.25-28. While each of the delivery system 200 and the delivery system 300is in some aspects different than the delivery system 100, it will beunderstood that components and features of the delivery system 100 asdescribed herein can apply to either or both of the delivery system 200and the delivery system 300. Similar or like items can perform the samefunction as those shown in the delivery system 100, and the features ofsuch items are not all discussed hereafter, for brevity.

Referring now to FIG. 15, with further reference to FIG. 1, across-sectional view of a region of a delivery system 200 is shown,wherein the delivery system 200 is similar in at least some aspects tothe delivery system 100 shown in FIG. 1. For example, the sectional viewof FIG. 15 can be taken along a line that positioned similarly as theline 2-2 in FIG. 1. As illustrated in FIG. 15, an inner shaft 210 can beat least partially disposed within a lumen of an outer shaft 220.Additionally, a stiffening wire 264 is provided between the outer shaft220 and the inner shaft 210. The stiffening wire 264 can be of stainlesssteel or another material and can influence the luminal space and shaftstiffness and/or flexibility without modifying the material thickness ofthe shaft. A guidewire 262 can be at least partially disposed within alumen of the inner shaft 210. A lumen defined between the outer shaft220 and the inner shaft 210 or within the inner shaft 210 can providefluid communication to a balloon for inflation and deflation of theballoon. In some embodiments, the outer shaft 220, the inner shaft 210,the guidewire 262, and/or stiffening wire 264 each have a circularcross-sectional shape and a single lumen. In other embodiments, however,the outer shaft 220, the inner shaft 210, the guidewire 262, and/orstiffening wire 264 can have other cross-sectional shapes, such as anovoid shape, a “C” shape, a rectangular shape, a triangular shape, orthe like, with multiple lumens. For example, the stiffening wire 264 canhave a shape that fits within the space between the outer shaft 220 andthe inner shaft 210. For example, the cross-sectional shape of thestiffening wire 264 can be polygonal (e.g., rectangular) orcrescent-shaped. The inner surface of the outer shaft 220 and/or theouter surface of the inner shaft 210 can have cross-sectional shapesthat accommodate and/or guide the stiffening wire 264. A support shaft230 can also be placed circumferentially around the inner shaft 210 orouter shaft 220 to increase column strength and stiffness of thecatheter region. In some embodiments, the support shaft 230 can have alarger inner diameter and be attached to the outer shaft 220 to extendthe overall catheter length and accommodate a larger proximal segment ofthe inner catheter 210 or stiffening wire 264. The support shaftplacement can vary from the entire length of the inner shaft 210 tospecific 10 cm, 20 cm, 30 cm, 40 cm segments of the inner shaft withvarying gaps of 10 cm, 20 cm, 30 cm, 40 cm length to increase overallcatheter stiffness. Attachment mechanisms may include bonding,reflowing, braiding, coiling, laser welding, etc. The support shaft 230can also be made of high durometer plastics such as nylon, Pebax®,stainless steel, Nitinol, polyether ether ketone (PEEK), etc.

A stabilizing wire 260 can be coupled to a stent. The stabilizing wire260 is slideably disposed within the outer shaft 220 and is sized andshaped to extend distally from the proximal end of the outer shaft andto extend proximally from a proximal end of a port. The stabilizing wire260 can be formed of plastic, such as high durometer plastic includingnylon, polyether ether ketone (PEEK), a metal, a metal alloy, such asnitinol, and/or combinations thereof. The stabilizing wire 260 can beconfigured to position the stent (not shown) at the desired treatmentlocation and to at least generally maintain the position of the stentwhile the outer shaft 220 is withdrawn as described in greater detailbelow.

The stabilizing wire 260 can be sized and shaped to extend proximallyfrom the proximal end of the port when the stent is positioned at thetarget site. For example, the stabilizing wire 260 can have a length ofabout 150 cm to about 180 cm and a suitable cross-sectional dimensionfor positioning within the patient's body lumen. The stabilizing wire260 can have a working length (i.e., a length that can be positionedwithin the target body lumen) of about 70 cm to about 300 cm, about 150cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300cm.

As shown in FIGS. 16-20, the delivery system 200 can be provided with astent 290 that is positioned proximal to an inflatable balloon 280 forexpansion and delivery of the stent 290 to a target delivery location.By positioning the stent 290 proximal to the inflatable balloon 280, thestent 290 and the balloon 280 are not overlapping (e.g., are axiallyoffset) while in a delivery state within the outer shaft 220, andthereby reduce the space requirements within the outer shaft 220.

As shown in FIG. 16, the delivery system 200 is provided with the outershaft 220 covering or ensheathing other components of the deliverysystem 200. For example, the outer shaft 220 can extend to a tip 215positioned at a distal end of the inner shaft 210. The inner shaft 210can extend within the outer shaft 220, with a length thereof accessibleproximal to a proximal end of the outer shaft 220 (e.g., at the outershaft hub 240). Additionally or alternatively, the connector 250 can beaccessible proximal to a proximal end of the outer shaft 220 (e.g., atthe outer shaft hub 240). A stabilizing wire 260 is also accessibleproximal to a proximal end of the outer shaft 220 (e.g., at the outershaft hub 240). A guidewire can be advanced ahead of the tip 215 (e.g.,through the inner shaft 210) to provide a pathway for advancement ofother components of the delivery system 200.

As shown in FIG. 17, the outer shaft 220 can be moved to unsheath aninflatable balloon 280. For example, once the distal region of thedelivery system 200 is positioned at a desired location, the outer shaft220 is configured to be at least partially proximally retracted relativeto the inner shaft 210 by retracting the outer shaft hub 240 relative tothe connector 250. Once the outer shaft 220 is partially retracted, atleast a portion of the balloon 280 is unsheathed.

As shown in FIG. 18, the outer shaft 220 can be further moved tounsheath a stent 290. Once the outer shaft 220 is further retracted, aportion of the stent 290 is unsheathed and protruding features 294 ofthe stent 290 are configured to radially expand outwardly away from theinner shaft 210. As shown, the balloon 280 is positioned at a distalportion 210 b of the inner shaft 210, and the stent 290 is positioned ata proximal portion 210 a of the inner shaft 210. The proximal portion210 a of the inner shaft 210 can have an outer cross-sectional dimensionthat is smaller than an outer cross-sectional dimension of the balloon280, thereby permitting the stent 290 to be collapsed onto the proximalportion 210 a in a smaller profile than would be achieved if the stent290 were collapsed onto the balloon 280.

As shown in FIG. 19, the outer shaft 220 has been retracted and thestent 290 is unsheathed. The stabilizing wire 260, accessible by a user,is configured engage with the proximal end of the stent 290 and controlthe position of the stent 290 during and after retraction of the outershaft 220. The user can secure the stabilizing wire 260 relative to theinner shaft 210 while the outer shaft 220 is retracted so that theposition of the stent 290 can be maintained with respect to the innershaft 210, including the balloon 280, during retraction of the outershaft 220.

As shown in FIG. 20, when both the stent 290 and the balloon 280 areunsheathed by the outer shaft 220 and exposed, the stent 290 can beaxially aligned with the balloon 280. Because the inner shaft 210extends through the stent 290, proximal retraction of the inner shaft210 relative to the stent 290 can achieve axially alignment of theballoon 280 with the stent 290. The balloon 280 can have an axial lengththat is greater than the axial length of the stent 290, so that anentirety of the stent 290 is overlapping with the balloon 280 whenaxially aligned. Additionally or alternatively, the inner shaft 210 andthe outer shaft 220 can be retracted together with respect to the stent290.

The balloon 280 can be inflated to expand or further expand the stent290. For example, an interior region of the balloon can be fluidlyconnected, via the inner shaft 210, to the port 252 of the connector250. By providing a fluid through the port 252, the balloon 280 can beexpanded, thereby expanding or further expanding the stent 290. Theexpansion with respect to target anatomy will be further discussedherein.

Following one or more of the above-described operations, the balloon 280can be deflated. The stent 290 can be maintained for any duration oftime in an expanded state. For example, the stent 290 can be maintainedfor a duration of time effective to provide therapeutic treatment (e.g.,remodeling and/or drug delivery) to target anatomy.

Additionally or alternatively, the delivery system 200 can be deployedat multiple locations. The stent 290 can be collapsed by moving theouter shaft 220 over the stent 290. Optionally, the stent 290 can beaxially realigned with the proximal portion 210 a of the inner shaft 210prior to collapse by the outer shaft 220. The stent 290 and the balloon280 can be moved to another target location, and one or more of theabove-described operations can be repeated.

Additionally or alternatively, the delivery system 200 can be removed.The stent 290 can be collapsed by moving the outer shaft 220 over thestent 290. Optionally, the stent 290 can be axially realigned with theproximal portion 210 a of the inner shaft 210 prior to collapse by theouter shaft 220. Components of the delivery system 200 can be removedfrom the patient by retracting proximally over the guidewire.

Additionally or alternatively, the stent 290 can be detached from thestabilizing wire 260 and left as an implant within the patient.Following detachment, other components of the delivery system 200 can beremoved from the patient by retracting proximally over the guidewire.

As shown in FIGS. 21-24, the delivery system 300 can be provided with astent 390 that is positioned distal to an inflatable balloon 380 forexpansion and delivery of the stent 390 to a target delivery location.By positioning the stent 390 distal to the inflatable balloon 380, thestent 390 and the balloon 380 are not overlapping (e.g., are axiallyoffset) while in a delivery state within the outer shaft 320, andthereby reduce the space requirements within the outer shaft 320.

As shown in FIG. 21, the delivery system 300 is provided with the outershaft 320 covering or ensheathing other components of the deliverysystem 300. For example, the outer shaft 320 can extend to a tip 315positioned at a distal end of the inner shaft 310. The inner shaft 310can extend within the outer shaft 320, with a length thereof accessibleproximal to a proximal end of the outer shaft 320 (e.g., at the outershaft hub 340). Additionally or alternatively, the connector 350 can beaccessible proximal to a proximal end of the outer shaft 320 (e.g., atthe outer shaft hub 340). A stabilizing wire 360 is also accessibleproximal to a proximal end of the outer shaft 320 (e.g., at the outershaft hub 340). A guidewire can be advanced ahead of the tip 315 (e.g.,through the inner shaft 310) to provide a pathway for advancement ofother components of the delivery system 300.

As shown in FIG. 22, the outer shaft 320 can be moved to unsheath aninflatable balloon 380. For example, once the distal region of thedelivery system 300 is positioned at a desired location, the outer shaft320 is configured to be at least partially proximally retracted relativeto the inner shaft 310 by retracting the outer shaft hub 340 relative tothe connector 350. Once the outer shaft 320 is partially retracted, aportion of the stent 390 is unsheathed and protruding features 394 ofthe stent 390 are configured to radially expand outwardly away from theinner shaft 310. The stabilizing wire 360, accessible by a user, isconfigured engage with the proximal end of the stent 390 and control theposition of the stent 390 during and after retraction of the outer shaft320. The user can secure the stabilizing wire 360 relative to the innershaft 310 while the outer shaft 320 is retracted so that the position ofthe stent 390 can be maintained with respect to the inner shaft 310,including the balloon 380, during retraction of the outer shaft 320.

As shown in FIG. 23, the outer shaft 320 can be further moved tounsheath a balloon 280. Once the outer shaft 320 is further retracted,at least a portion of the balloon 380 is unsheathed. As shown, theballoon 380 is positioned at a proximal portion 310 a of the inner shaft310, and the stent 390 is positioned at a distal portion 310 b of theinner shaft 310. The distal portion 310 b of the inner shaft 310 canhave an outer cross-sectional dimension that is smaller than an outercross-sectional dimension of the balloon 380, thereby permitting thestent 390 to be collapsed onto the distal portion 310 b in a smallerprofile than would be achieved if the stent 390 were collapsed onto theballoon 380.

As shown in FIG. 24, when both the stent 390 and the balloon 380 areunsheathed by the outer shaft 320 and exposed, the stent 390 can beaxially aligned with the balloon 380. Because the inner shaft 310extends through the stent 390, distal movement of the inner shaft 310relative to the stent 390 can achieve axially alignment of the balloon380 with the stent 390. The balloon 380 can have an axial length that isgreater than the axial length of the stent 390, so that an entirety ofthe stent 390 is overlapping with the balloon 380 when axially aligned.

The balloon 380 can be inflated to expand or further expand the stent390. For example, an interior region of the balloon can be fluidlyconnected, via the inner shaft 310, to the port 352 of the connector350. By providing a fluid through the port 352, the balloon 380 can beexpanded, thereby expanding or further expanding the stent 390. Theexpansion with respect to target anatomy will be further discussedherein.

Following one or more of the above-described operations, the balloon 380can be deflated. The stent 390 can be maintained for any duration oftime in an expanded state. For example, the stent 390 can be maintainedfor a duration of time effective to provide therapeutic treatment (e.g.,remodeling and/or drug delivery) to target anatomy.

Additionally or alternatively, the delivery system 300 can be deployedat multiple locations. The stent 390 can be collapsed by moving theouter shaft 320 over the stent 390. Optionally, the stent 390 can beaxially realigned with the proximal portion 310 a of the inner shaft 310prior to collapse by the outer shaft 320. The stent 390 and the balloon380 can be moved to another target location, and one or more of theabove-described operations can be repeated.

Additionally or alternatively, the delivery system 300 can be removed.The stent 390 can be collapsed by moving the outer shaft 320 over thestent 390. Optionally, the stent 390 can be axially realigned with theproximal portion 310 a of the inner shaft 310 prior to collapse by theouter shaft 320. Components of the delivery system 300 can be removedfrom the patient by retracting proximally over the guidewire.

Additionally or alternatively, the stent 390 can be detached from thestabilizing wire 360 and left as an implant within the patient.Following detachment, other components of the delivery system 300 can beremoved from the patient by retracting proximally over the guidewire.

As shown in FIGS. 25-28, a delivery system 500 can be provided with astent 590 that is positioned over an inflatable balloon 580 forexpansion and delivery of the stent 590 to a target delivery location.By positioning the stent 590 over and about the inflatable balloon 580,the stent 590 is ready to be expanded by the balloon 580 immediatelyupon partial or complete unsheathing with respect to the outer shaft520. Any released portion of a stent 590 can be expanded by anunderlying portion of a balloon 580 that is similarly released.

As shown in FIG. 25, the delivery system 500 is provided with the outershaft 520 covering or ensheathing other components of the deliverysystem 500. For example, the outer shaft 520 can extend to the tip 515positioned at a distal end of the inner shaft 510. The inner shaft 510can extend within the outer shaft 520, with a length thereof accessibleproximal to a proximal end of the outer shaft 520 (e.g., at the outershaft hub 540). Additionally or alternatively, the connector 550 can beaccessible proximal to a proximal end of the outer shaft 520 (e.g., atthe outer shaft hub 540). As discussed above, a guidewire can beadvanced ahead of the tip 515 (e.g., through the inner shaft 510) toprovide a pathway for advancement of other components of the deliverysystem 500.

As shown in FIG. 26, the outer shaft 520 can be moved to unsheath aportion of the stent 590 and other components of the delivery system500. For example, once the distal region of the delivery system 500 ispositioned at a desired location, the outer shaft 520 is configured tobe at least partially proximally retracted relative to the inner shaft510 by retracting the outer shaft hub 540 relative to the connector 550.Once the outer shaft 520 is partially retracted, a portion of the stent590 and/or the balloon 580 is unsheathed and protruding features 594 ofthe exposed portion of the stent 590 are configured to radially expandoutwardly away from the inner shaft 510.

The stent 590 can be fixedly attached to another component of thedelivery system 500, such as the inner shaft 510 (e.g., via an anchorportion). Alternatively, the stent 590 can be adjustably positionedrelative to one or more other components of the delivery system 500. Forexample, the stent 590 can be coupled to a stabilizing wire that isaccessible to a user at a proximal end of the delivery system 500, andthe user can adjust a position of the stent 590 by operation of thestabilizing wire.

As shown in FIG. 27, the outer shaft 520 has been partially retractedand the stent 590 is partially unsheathed. The stent 590 can beconnected to the inner shaft 510, for example with a stabilizing wire(not shown), as described herein. Accordingly, the position of the stent590 can be maintained with respect to the inner shaft 510, including theballoon 580. For example, while some adjustment of the length and/oraxial position of the stent 590 may occur during radial expansion of thestent 590, it will be understood that the stabilizing wire can maintainthe position of at least a portion of the stent 590 to be around andaxially aligned with at least a portion of the balloon 580. Additionallyor alternatively, the stent 590 can be secured relative to the outershaft 520 by locking the outer shaft hub 540 relative to the inner shaft510 at a proximal portion of the delivery system 500. For example, alocking member can be controllably engaged and disengaged to selectivelylock relative axial positions and/or movement of the outer shaft hub 540and the inner shaft 510. Such a locking member, when engaged can preventproximal retraction of the outer shaft 520 when the balloon 580 isexpanded, including portions of the balloon 580 that are within theouter shaft 520. The balloon 580 can have an axial length that isgreater than the axial length of the stent 590, so that an entirety ofthe stent 590 is overlapping with the balloon 580.

An extent to which the stent 590 and/or the balloon 580 are unsheathed(e.g., partially unsheathed) can be determined by one or more of avariety of mechanisms. For example, the stent 590, the balloon 580, theouter shaft 520, and/or one or more other components coupled to one ormore of the above can include a visualization marker, such as aradiopaque marker. The position of such components relative to eachother and/or a target location can be determined visually, for exampleby an imaging technique (e.g., angiography). Additionally oralternatively, the relative positions of the stent 590, the balloon 580,and/or the outer shaft 520 can be determined and/or inferred bycorresponding components at a proximal end of the delivery system 500.For example, the positions the outer shaft hub 540, the inner shaft 510,and/or a stabilizing wire (not shown) can be compared to determine therelative positions of the outer shaft 520, the balloon 580, and/or thestent 590, respectively. Appropriate markers, detents, or otherindicators can be provided on the outer shaft hub 540, the inner shaft510, and/or a stabilizing wire (not shown) at the proximal end of thedelivery system 500 for reference by a user. For example, such markers,detents, or other indicators can be incrementally spaced apart from eachother to indicate to the user a position of the outer shaft hub 540 withrespect to the inner shaft 510. Such an indication can be correlatedwith an extent to which the stent 590 is unsheathed.

When both the stent 590 and the balloon 580 are partially unsheathed bythe outer shaft 520, the initially exposed portion of the balloon 580can be inflated to expand or further expand the stent 590. For example,an interior region of the initially exposed portion of the balloon 580can be fluidly connected, via the inner shaft 510, to the port 552 ofthe connector 550. By providing a fluid through the port 552, theinitially exposed portion of the balloon 580 can be expanded, therebyexpanding or further expanding the initially exposed portion of thestent 590. Other portions of the stent 590 and/or the balloon 580 canremain within the outer shaft 520. Expansion can be performed, forexample, while the outer shaft 520 is locked relative to the inner shaft510 (e.g., with the outer shaft hub 540). Such locking can prevent theouter shaft 520 from further retracting in response to forces due toexpansion of the partially exposed stent 590 and/or balloon 580. Theexpansion with respect to target anatomy will be further discussedherein.

Following an initial deployment, additional operations can be performedto expand the stent 590 in a subsequent stage of the same procedure. Forexample, a different length and/or portion of the stent 590 can beutilized in a subsequent operation. As shown in FIG. 28, the outer shaft520 has been further retracted and the stent 590 is further unsheathed.When both the stent 590 and the balloon 580 are more fully unsheathed bythe outer shaft 520, the more fully exposed portion of the balloon 580can be inflated to expand or further expand the more fully exposedportion of the stent 590, for example via the port 552, as discussedherein. Other portions of the stent 590 and/or the balloon 580 canremain within the outer shaft 520. As described above, expansion can beperformed while the outer shaft 520 is locked relative to the innershaft 510 (e.g., with the outer shaft hub 540) to stabilize the systemduring inflation of the balloon 580.

An extent to which the stent 590 and/or the balloon 580 are unsheathed(e.g., further unsheathed) can again be determined by one or more of avariety of mechanisms, such as those described above with respect todetermining an extent of partial unsheathing.

In some embodiments, the operating length of the stent 590 that isunsheathed, exposed, and/or expanded in the operations described abovecan be of different lengths. For example, the operating length can beshorter in an initial stage and longer in a subsequent stage.Alternatively, the operating length can be longer in an initial stageand shorter in a subsequent stage.

Where different operating lengths are desired, the balloon 580 canoptionally include multiple segments that are independently inflatable.For example, the balloon 580 can include multiple segments that arealigned at different axial locations along the inner shaft 510. Theinner shaft 510 can provide multiple lumens each connecting tocorresponding ports. A fluid can be provided through a selected numberof the ports to inflate only the corresponding balloon segments. Forexample, only the balloon segments that are outside of the outer shaft520 can be inflated to expand corresponding portions of the stent 590.Additionally or alternatively, the balloon segments can be in fluidcommunication with each other such that they are inflated in a sequence.

Between an initial expansion (e.g., the expansion illustrated in FIG.27) and a subsequent expansion (e.g., the expansion illustrated in FIG.28), the stent 590 and/or the balloon 580 can be deflated, compressed,and/or at least partially retracted into the outer shaft 520.Alternatively, the stent 590 and/or the balloon 580 can be furtherexposed by unlocking the outer shaft 520 from the inner shaft 510 andallowing the outer shaft 520 to further retract in response to forcesfrom the inflated balloon 580.

The transition from an initial expansion to a subsequent expansion canbe performed to adjust an operating length of the stent 590 to morefully address a target region. For example, an initial operating lengthof the stent 590 can be exposed and expanded. The user can then evaluatethe effectiveness of the operation (e.g., via imaging technique such asangiography). Where the initial operating length of the stent 590 isdetermined to be insufficient, the stent 590 and/or the balloon 580 canbe further exposed to increase the operating length of the stent 590.Such adjustments can be made as needed until an adequate operatinglength is provided. It will be recognized that the ability to performsuch adjustments may avoid the need to remove a stent that is discoveredto be inadequate and replace it with a different stent or other devicethat provides an adequate operating length. By eliminating these steps,total operation time can be reduced. Additionally, a user can desire todeploy a device with an operating length that is adequately long (e.g.,to span a target region) without being longer than is required (e.g., toavoid operating on regions outside the target region). It will berecognized that the user can provide a single stent 590 with anadjustable operating length to adequately address a target region thathas an initially uncertain length or where the required operating lengthof the stent is otherwise unknown or uncertain. Such capabilities reducethe burden on the user to accurately select the devices with the correctoperating length at the beginning of an operation. Furthermore, thecapabilities described herein also reduce the need to provide a widearray of devices that provide different performance characteristics, asa single device or reduced number of devices can be operated asdescribed herein to provide a desirably wide range of performancecharacteristics.

The transition from an initial expansion to a subsequent expansion canbe performed to address different operating length requirements ofdifferent target regions. Between an initial expansion and a subsequentexpansion, the stent 590 and/or the balloon 580 can be repositioned to adifferent location. For example, the stent 590 can be repositioned toalign with a different target region. Where the new target region has adifferent length or other feature relative to an initial target region,the operating length of the stent 590 can be selected and/or modifiedaccordingly to adequately address each of the target regions. It will berecognized that the ability to perform such adjustments may avoid theneed to remove a stent suitable for an initial target region and replaceit with a different stent that is suitable for a different targetregion. By eliminating these steps, total procedure time can be reduced,thereby reducing risks associated with long procedure times.Additionally, it will be recognized that the user can provide a singlestent 590 with an adjustable operating length to adequately address eachof different target regions despite each target region havingpotentially different requirements for an operating length of the stent590. This allows a user with greater flexibility and options throughouta procedure with a single device.

Following one or more of the above-described operations, the balloon 580can be deflated. The stent 590 can be maintained for any duration oftime in an expanded state. For example, the stent 590 can be maintainedfor a duration of time effective to provide therapeutic treatment (e.g.,remodeling and/or drug delivery) to target anatomy and allows fluid flowthrough the expanded stent and deflated balloon where there is no fluidblockage through the treated site.

Additionally or alternatively, the delivery system 500 can be deployedat multiple locations. The stent 590 can be collapsed by moving theouter shaft 520 over the stent 590. The stent 590 and the balloon 580can be moved to another target location, and one or more of theabove-described operations can be repeated.

Additionally or alternatively, the delivery system 500 can be removed.The stent 590 can be collapsed by moving the outer shaft 520 over thestent 590. Components of the delivery system 500 can be removed from thepatient by retracting proximally over the guidewire.

Additionally or alternatively, the stent 590 can be detached from theinner shaft 510 and left as an implant within the patient. Followingdetachment, other components of the delivery system 500 can be removedfrom the patient by retracting proximally over the guidewire.

Referring now to FIGS. 29-32, an example of a delivery system 400 isshown in various configurations to deliver, position, deploy, and/orrecapture a stent. The operations described with respect to the deliverysystem 400 can be applied to the delivery system 100, the deliverysystem 200, the delivery system 300, and/or the delivery system 500. Asshown in FIG. 29, the delivery system 400 is in a delivery state withina body lumen 710 (e.g., a blood vessel) of a human patient. In thisembodiment, the delivery system 400 is configured for intraluminal(e.g., intravascular) delivery through the blood vessel, (e.g., femoralartery) of a human patient. The femoral artery can be accessed byintroducing a sheath (e.g., 5F or 6F) into the lumen of the femoralartery. The delivery system 400 is delivered into the body lumen bytracking the distal portion 410 b of the inner sheath over the guidewireand distally advancing the delivery system 400 to a desired location 720within the vessel. In some embodiments, an angioplasty procedure isperformed at the desired location 720 before the delivery system 400 isadvanced to the desired location 720.

Once the delivery system 400 is positioned at the desired location 720,the distal portion 420 b of the outer sheath is proximally retracted tounsheath the stent 490. In the illustrated embodiment, the body of thestent 490 is at least partially expanded when unsheathed and theprotruding features 494 are collapsed. However, the protruding features494 can be configured to expand once the distal portion 420 b of theouter sheath is retracted. In other embodiments, the stabilizing wire(not shown) can be distally advanced and fixed, such as held or pinned,or fixed at the desired location to position the stent before, during,and/or after the outer sheath is proximally retracted to deploy thestent. As illustrated, the tip 415 of delivery system 400 is positioneddistally from the distal end of the stent and the inner shaft 410remains positioned within at least a portion of the lumen of the stent190.

In the deployed state, the protruding features 494 of the stent 490 areconfigured to expand radially and are further configured to pierce thelumen wall at the desired location once the deployed stent 490 isexpanded into contact with the vessel wall (see FIGS. 29 and 30). Aswill be explained in greater detail below, stents and other expandablestructures can be configured to at least partially self-expand, such asexpanding outwardly from the collapsed/delivery state to the deployedand/or expanded state when the stents and other expandable structuresare at least partially unsheathed from the outer shaft. In someembodiments, stents and other expandable structures are configured toexpand when operably coupled with an expandable element or mechanism,such as a balloon. In additional embodiments, self-expanding stents andother structures are configured to further expand when coupled to theexpansion mechanism. Regardless of whether the stents and otherexpandable structures are self-expanding or expand when coupled to theexpandable element, the stents and others expandable structures can beconfigured to expand radially (symmetrically or asymmetrically). In someembodiments, the at least partially expanded stents and other expandablestructures can be configured to position at least some of the protrudingfeatures perpendicular to the vessel wall.

As shown in FIGS. 29 and 30, the delivery system 400 is configured forinsertion of a balloon 480 coupled to the inner shaft 410. The balloon480 is further configured to be positioned within the stent lumen andexpanded therein to further expand the stent 490 between the deliverystate and the expanded, deployed state. In some embodiments, the balloon480 can be coated with a drug-delivery coating and a drug, such as thecoatings and drugs described herein. As further discussed elsewhereherein, the stent 490 can be operatively coupled to an actuationmechanism, such as a mechanical actuation mechanism (e.g., stabilizingwire, stent pull wire, pusher shaft, or a combination thereof),configured to position, expand, retract, re-position, and/or remove thestent 490 from the body lumen.

FIG. 30 shows a cross-sectional view of a region of the delivery system400 in the deployed state within the body lumen. As shown in FIG. 30,the stent 490 is expanded within the vessel by a balloon 480. To expandthe deployed stent 490, the balloon 480 is coupled to inner shaft 410and distally advanced into a lumen of the deployed stent 490 until adistal tip 415 of the inner shaft 410 is positioned near a distal end490 b of the deployed stent 490. As illustrated, the distal end 490 b ofthe stent 490 can include radiopaque markers 490 c. Additionally oralternatively, radiopaque markers 490 c may be located elsewhere in thedelivery system 400, or may be omitted from the delivery system 400.

FIG. 31 shows a cross-sectional view of a portion of the delivery system400 in a deployed state with the stent 490 having protruding features494 expanded within and piercing a portion of the vessel wall. Asillustrated in FIG. 31, the balloon 480 is deployed and radiallyexpanded to engage with and further expand the stent 490 into contactwith the lumen vessel. When the stent 490 is expanded, the protrudingfeatures 494 penetrate further into the wall.

FIG. 32 shows a cross-sectional view of the delivery system 400 in atreatment state. In the treatment state, the balloon 480 has beendeflated. As illustrated, the distal portion 410 b of the inner shaft410 remains in the body lumen. Following deflation of the balloon 480,the stent 490 remains expanded into contact with the lumen wall and theprotruding features 494 remain penetrated into the wall. Any drugscarried by the protruding features 494 are at least partially releasedinto the body lumen wall at the treatment state. Optionally, the stent490 can be affixed to the balloon 480, such as by crimping the stent 490to at least partially surround the balloon 480, such that the stent 490is both expanded and collapsed by inflating and deflating the balloon480, respectively.

While the stents described herein have the features shown, it will beunderstood that a variety of different stents and other devices can beused with the delivery systems described herein. Various features areset forth below by way of example, and not by limitation.

Regarding such stents and other devices, the material(s) for forming theframe, struts, and/or protruding features described herein can beselected based on mechanical and/or thermal properties, such asstrength, ductility, hardness, elasticity, flexibility, flexuralmodulus, flexural strength, plasticity, stiffness, emissivity, thermalconductivity, specific heat, thermal diffusivity, thermal expansion, anyof a variety of other properties, or a combination thereof. If formedfrom a material having thermal properties, the material can be activatedto deliver thermal treatment to the desired treatment site. Regardlessof the material, the frame, struts, and/or protruding features can beformed from a tube or a wire, such as a solid wire, by laser cutting orother suitable techniques. When formed from the wire, a portion of thewire can be removed by chemical etching or another suitable method tocreate an inner dimension of the stent.

Stents (e.g., the frame and the struts) can be sized and shaped forplacement within various body lumens, including blood vessels, while notrupturing the vessel. For example, several stents and other structurescan have radial strength that allows for features of the body lumen(e.g., vessel wall) to receive drugs without dissection or damagethereto. Vessels in which the stents described herein may be sized andshaped for placement include arteries, such as coronary arteries,peripheral arteries, carotid arteries, circle of willis, anteriorcerebral artery, middle cerebral artery, posterior cerebral artery, anyof the lenticulostriate arteries, renal arteries, femoral arteries,veins, such as cerebral veins, saphenous veins, arteriovenous fistulas,or any other vessel that may contain a treatment site. Stents can have avariety of shapes, including a cube, a rectangular prism, a cylinder, acone, a pyramid, or variations thereof.

Stents and other structures having protruding features can include avariety of dimensions (in both the low-profile delivery state andexpanded deployed state). These embodiments can provide for expansionthat enables usage in a variety of situations covering a wide range ofdimensions, such as to treat and/or prevent dissection. Regardless ofthe shape, stents can have a length of about 0.25 mm, about 0.5 mm,about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm,about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14mm, about 16 mm, about 18 mm, about 20 mm, about 30 mm, about 40 mm,about 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, orabout 100 mm. In addition, a stent shaped into a cube, a rectangularprism, or a pyramid can have a width of about 0.25 mm, about 0.5 mm,about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm,about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14mm, about 16 mm, about 18 mm, about 20 mm, about 25 mm, or about 30 mm.Moreover, a stent shaped into a cylinder or a cone can have a diameterof about 0.25 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm,about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 50mm. The width or the diameter of the stent can decrementally decreasealong a length of the stent. In addition, the stent can be sized andshaped to prepare the body lumen for certain procedures, such as a stentplacement procedure.

A stent and/nor other expandable structures in the expanded state canhave a cross-sectional dimension of about 2 mm to about 10 mm, inclusiveof the expanded protruding features. For example, a frame can have across-sectional dimension of about 1 mm to about 9 mm and the protrudingfeatures can each have a length from about 0.1 mm to about 1.5 mm. Insome embodiments, the stent has an overall cross-sectional dimension ofabout 4 mm with the frame having a cross-sectional dimension of about 2mm and the protruding features each having a length of about 1 mm. Insome embodiments, the stent has an overall cross-sectional dimension ofabout 6 mm with the frame having a cross-sectional dimension of about 4mm and the protruding features each having a length of about 1 mm. Infurther embodiments, the protruding features can have a plurality oflengths such that the length of the protruding features of a stent orother expandable structure differs. For example, a stent can includeprotruding features having a length of about 0.2 mm, about 0.5 mm, andabout 1 mm.

Profiles of the stents or other structures can be sized such that thestents or other structures are compatible with a wide range of cathetersizes. Embodiments in accordance with the present technology can includestents or other structures designed to receive a guidewire, such asguidewires having a diameter of 0.010, 0.014, 0.018, 0.035, or 0.038inch. In several embodiments, the stent or scaffold structure can besized and designed for delivery via a micro-catheter that it is pushedthrough. In some embodiments, stents or structures can be incorporatedinto a delivery system, including modular or single unit deliverysystems.

Stents and other structures described herein can include a marking forvisualization of the stent within the body lumen, such as one or moreradiopaque markers. The radiopaque markers can be formed from ClearfilPhoto Core PLT®, tantalum, titanium, tungsten, barium sulfate, andzirconium oxide, or another suitable radiopaque marking. The markingscan be formed on a proximal portion of the stent, a distal portion, anintermediate portion, or a combination thereof. The markings can be aband, a coil, a clip, filled into one or more portions of a tube in thestent, plated onto one or more portions of the stent, or a combinationthereof. Regardless of the type of marking, the marking can be coined,swaged, wrapped, or encased along, or onto any portion of the stent.

Stents and other structures can be flexible enough to track throughvarious anatomical features, including those having a curvature. Theflexible properties of the stent and other structures can be provided bythe material from they are formed. In addition, flexible properties canalso be provided by fracturing one or more of the members engaging withand extending between two or more rows of struts. Additionally, thestent or other structure can be readily deployed and expanded, andretracted and contracted. The stent or other structure can also bereadily repositioned within a vessel or other body lumen.

In several embodiments, a drug-eluting compound is coated onto at leasta portion of the protruding features, the frame, the struts, and/or theballoon. The coating can be any suitable coating known to one ofordinary skill in the art suitable to deliver the drug to the wall. Forexample, suitable coatings include, but are not limited to a snowcoating or a crystalline coating having edges configured to remain inthe wall. The drug-eluting compound can be a synthetic or biologicalpolymer coated into a variety of different patterns and thicknessessuitable for delivering the drug contained therein. In otherembodiments, the protruding features themselves may be composed ofdrug-eluting materials. The drug carried by the drug-eluting compoundand/or the protruding features in accordance with the present technologycan be any drug suitable for treating the treatment site in which thestent will be placed and may or may not include an excipient. Forexample, the drug can be an anti-proliferative, an anti-neoplastic, amigration inhibitor, an enhanced healing factor, an immunosuppressive,an anti-thrombotic, a blood thinner, or a radioactive compound. Examplesof anti-neoplastics include, but are not limited to, siroliums,tacrolimus, everolimus, leflunomide, M-prednisolone, dexamethasone,cyclosporine, mycophenolic acid, mizoribine, interferon, and tranilast.Examples of anti-proliferatives include, but are not limited to,taxol/paclitaxel, actinomycin, methotrexate, angiopeptin, vincristine,mitmycine, statins, c-myc antisense, Abbot ABT-578, RestinASE,2-chloro-deoxyadenosine, and PCNA ribozyme. Examples of migrationinhibitors, but are not limited to, include batimistat, prolylhydrosylase, halofunginone, c-preteinase inhibitors, and probucol.Examples of enhanced healing factors include, but are not limited to,BCP 671, VEGF, estradiols, NO donor comounds, and EPC antibodies.Examples, of radioactive compounds include, but are not limited to,strontium-89 chloride (Metastron®), samarium-153 (Quadramet®),radium-223 dichloride (Xofigo®), yttrium-90, and iodine-131. In someembodiments, the drug-eluting compound and/or the protruding featurescan carry more than one drug.

In some embodiments, the protruding features can include textured (e.g.,ribbed) surfaces which is expected to provide greater surface area fordrug-delivery. Moreover, any protruding features can include a texturedsurface such as a ribbed surface (vertical, horizontal, radial, orcircular relative to a longitudinal plane of the protruding feature), across-hatched surface, an isotropic surface, or other surface typessuitable for providing greater surface area for drug-delivery.

The protruding features can be sized and shaped to engage with and/orpenetrate an occlusion, a neointima, an intima, an internal elasticlamina (IEL) a media, an external elastic lamina (EEL), an adventitia,or a combination thereof. The protruding features can also be sized andshaped to engage with and/or penetrate a tissue and/or structureadjacent to the body lumen in which the stent is to be placed while notrupturing the body lumen. For example, the stent can include squareprotruding features sized and configured to penetrate into the intimaand/or the media of a body lumen, pointed protruding features sized andconfigured to penetrate and extend into the media, and/or the IEL. Inaddition, protruding features can be configured to bend in one or moredirections relative to a longitudinal axis of the stent to engage withand/or penetrate a portion of the body lumen described herein. Inseveral embodiments, the protruding features can penetrate deeper intothe wall of a diseased body lumen, such as a vessel, compared to a stentlacking protruding features. In addition, the stent can allow for bloodto flow even while in the expanded position and with drug-elutingon-going.

Various protruding features described herein can deliver drugs deeperinto a vessel wall than possible via angioplasty balloons or otherexisting devices. In addition to carrying one or more drugs fortreatment of the site, the protruding features can also carry a moleculesuitable for degrading a portion of the occlusion, neointima, and/orintima to allow the protruding features to penetrate deeper in to thevessel wall than without the molecule. For example, the moleculesuitable for degradation can be an enzyme, such as elastase,collagenase, or a proteinase, such as, metalloproteinases, serineproteinases, cysteine proteinases, extracellular sulfatases,hyaluronidases, lysyl oxidases, lysyl hydroxylases, or a combinationthereof.

Further, it will also be appreciated that stents can carry one or moreprotruding features on one or more portions of the stent. For example,the stents can carry about 5 protruding features, about 10 protrudingfeatures, about 15 protruding features, about 20 protruding features,about 30 protruding features, about 40 protruding features, about 50protruding features, about 60 protruding features, about 70 protrudingfeatures, about 80 protruding features, about 90 protruding features, orabout 100 protruding features. The protruding features can be carried bythe frame, the struts, or a combination thereof. The number ofprotruding features can vary depending upon, for example, the targettreatment site, the type of drug being delivered, and size of the stent,etc. In addition, the protruding features carried by the stent can bedifferent types of the protruding features disclosed herein.

In some embodiments, once positioned against a body lumen wall (e.g., avessel wall), tissue and/or fluid can interact with the protrudingfeature to dissolve the drug and selectively release it from thereservoir. In other embodiments, the protruding feature can beconfigured to deliver the drug via a variety of means once the stent isexpanded. Protruding features are accordingly expected to provide aneffective means for selectively delivering a drug to a desired location,while reducing inadvertent loss or release of drugs. In otherembodiments, the stent can include more than one protruding feature, ora protruding feature having more than one reservoir. In severalembodiments, the stent including protruding features can have theprotruding feature, such as the coating or the reservoir, concealed(e.g., recessed) until the stent is positioned at the treatment site.Once positioned at the target site, the protruding feature can berevealed (e.g., expanded/projected, etc.) during and/or after expansionof the stent. This is expected to reduce any loss of the drug carried bythe protruding feature during delivery to the treatment site.

In some embodiments, the stents can further include a material (e.g.,PTFE, Dacron, polyamides, such as nylon and/or polyurethane basedmaterials, silicone, etc.) positioned over a stent, scaffold or otherstructure having protruding features covering at least a portion of theouter surface area. In some embodiments, the material covers the entireouter surface area. The material can be a mesh or a braid. In someembodiments, the material can be configured to increase a surface areaof the stent useful for providing additional surface area of the stentfor coating with a drug. In other embodiments, the material can furtherbe configured to allow blood flow through the inner diameter of thestent and/or limit blood flow to an outer dimension of the stent. Inadditional embodiments, the material can create a barrier between fluidflow (e.g., blood flow) and the drug-delivery locations. In addition,the material can be configured to prevent debris from the wall of thebody lumen from entering the bloodstream. In such embodiments, theassociated systems and devices can be used for temporary dissectiontacking or coverage of a region that may have been perforated during aprocedure.

The embodiments described herein provide delivery systems for one ormore structures having a means for delivering drugs to a specific regionwithin a body lumen, such as the vasculature, while still allowing fluid(e.g., blood) to flow through the treatment area where the structure hasbeen placed and/or other devices or treatment means within the adjacentbody lumen. In some embodiments, the fluid is temporary prevented fromflowing through the treatment area while one or more regions of systemsis delivered, deployed, positioned, and/or removed from the body lumen.In addition, the delivery systems can be configured to prepare the bodylumen for treatment, by raking the stent, pulling the stent, turning thestent, or a combination thereof, proximal or distal to the treatmentsite. In other embodiments, the delivery systems can be configured torotate the stent when mechanical force is applied.

The systems disclosed herein can provide for adjustment, recapture,and/or redeployment of the associated stents or other structures, and/ordeployment of a different stent or other structure, allowing apractitioner to more effectively to treat a desired region moreaccurately and deliberately. In several embodiments, the stent or otherdelivery structure can be deployed for a temporary period (e.g., forless than 24 hours), and then retracted and removed. In theseembodiments, the protruding features can engage with and/or pierce thelumen wall and remain therein after the stent or other deliverystructure is removed, or can be retracted and removed with the stent orother delivery structure. The stent can be configured to self-expand, orpartially self-expand, when deployed from the delivery system and alsobe configured to further expand within the body lumen when the balloonis expanded therein. The stent can also be configured to post-dilatewhen removed from the body lumen. In other embodiments, the stent orother delivery structure can be deployed for a long-term temporaryperiod (e.g., for less than 2 weeks, less than one month, less than 6months, less than one year), and then retracted and removed. In someembodiments, a different stent or delivery structure can be deployedafter a first stent or delivery structure has been retraced and removed.The duration of deployment and duration after removal before deploymentof the different stent or delivery structure can vary from minutes, tohours, to days, to weeks, to months, or to years. In these embodiments,removal of the first stent or delivery structure and deployment of adifferent stent or delivery structure can occur once, twice, threetimes, four times, five times, six times, seven times, eight times, ninetimes, or ten times. Moreover, the embodiments described herein canallow for a lower profile system than currently available systems.

In the embodiments described herein and other embodiments configured inaccordance with the present technology, stents and other expandablestructures may include non-protruding features, such as deployableand/or expandable features, that are not configured for delivering adrug to a target location. For example, stents and other expandablestructures configured in accordance with the present technology caninclude one or more protruding features, one or more non-protrudingfeatures, or combinations thereof.

While many embodiments of the stents and/or structures described hereininclude stents, additional embodiments of the expandable elements, suchas stents and/or structures, can include non drug-eluting stents and/ornon drug-eluting structures. In these embodiments, the non drug-elutingstents may include one or more protruding members, such as spikes. Thespikes can be configured to engage with and/or penetrate a portion ofthe body lumen or vessel. For example, the spikes can penetrate thevessel wall, thereby reducing and/or eliminating an elasticity of thevessel wall. In these embodiments, the protruding members can beconfigured to prevent the vessel wall from progressing inward toward thebody lumen and restricting and/or constricting flow therein. Theprotruding members can be integrally formed with the struts, or disposedon the surface of the struts, extending radially outward from the strutstoward the target tissue.

Various examples of aspects of the disclosure are described below asclauses for convenience. These are provided as examples, and do notlimit the subject technology.

Clause A: a delivery system comprising: an outer shaft; an inner shaftslideably disposed within the outer shaft and comprising an inflatableballoon; a guidewire slideably disposed within the inner shaft; and astent disposed around the balloon and fixedly coupled to the innershaft.

Clause B: a method for delivering a stent within a body lumen of apatient, the method comprising: delivering an outer shaft ensheathing aninner shaft and a stent to a target treatment site within the body lumenof the patient, the stent being disposed around a balloon of the innershaft and fixedly coupled to the inner shaft; proximally retracting theouter shaft to at least partially unsheath the stent; radially expandingthe stent to an expanded state by expanding the balloon; and piercingthrough a portion of a wall of the body lumen with one or moreprotruding features of the stent.

Clause C: a delivery system comprising: an outer shaft; an inner shaftslideably disposed within the outer shaft and comprising an inflatableballoon on a distal portion of the inner shaft; a guidewire slideablydisposed within the inner shaft; and a stent slideably disposed withinthe outer shaft and on a proximal portion of the inner shaft that isproximal to the balloon, the stent being connected to a stabilizing wirethat is slideably disposed within the outer shaft.

Clause D: a method for delivering a stent within a body lumen of apatient, the method comprising: delivering an outer shaft ensheathing aninner shaft and a stent to a target treatment site within the body lumenof the patient, the stent being slideably disposed within the outershaft and on a proximal portion of the inner shaft that is proximal to aballoon of the inner shaft; proximally retracting the outer shaft to atleast partially unsheath the stent and the balloon; moving the innershaft proximally relative to the stent until the stent is axiallyaligned with the balloon; radially expanding the stent to an expandedstate by expanding the balloon; and piercing through a portion of a wallof the body lumen with one or more protruding features of the stent.

Clause E: a delivery system comprising: an outer shaft; an inner shaftslideably disposed within the outer shaft and comprising an inflatableballoon on a proximal portion of the inner shaft; a guidewire slideablydisposed within the inner shaft; and a stent slideably disposed withinthe outer shaft and on a distal portion of the inner shaft that isdistal to the balloon, the stent being connected to a stabilizing wirethat is slideably disposed within the outer shaft.

Clause F: a method for delivering a stent within a body lumen of apatient, the method comprising: delivering an outer shaft ensheathing aninner shaft and a stent to a target treatment site within the body lumenof the patient, the stent being slideably disposed within the outershaft and on a distal portion of the inner shaft that is distal to aballoon of the inner shaft; proximally retracting the outer shaft to atleast partially unsheath the stent and the balloon; moving the innershaft distally relative to the stent until the stent is axially alignedwith the balloon; radially expanding the stent to an expanded state byexpanding the balloon; and piercing through a portion of a wall of thebody lumen with one or more protruding features of the stent.

Clause G: a method for delivering a stent within a body lumen of apatient, the method comprising: delivering an outer shaft ensheathing aninner shaft and a stent to a target treatment site within the body lumenof the patient, the stent being disposed around a balloon of the innershaft and fixedly coupled to the inner shaft; proximally retracting theouter shaft to partially unsheath the stent; radially expanding a firstlength of the stent to an expanded state by expanding the balloon whilea portion of the stent is within the outer shaft until one or moreprotruding features of the stent pierces through a first portion of awall of the body lumen; proximally retracting the outer shaft to furtherunsheath the stent; and radially expanding a second length of the stentto an expanded state by expanding the balloon until one or moreprotruding features of the stent pierces through a second portion of thewall of the body lumen.

One or more of the above clauses can include one or more of the featuresdescribed below. It is noted that any of the following clauses may becombined in any combination with each other, and placed into arespective independent clause, e.g., clause A, B, C, D, E, F, or G.

Clause 1: a connector at a proximal end of the inner shaft, theguidewire extending through the connector, the connector comprising aport in fluid communication with the balloon; and an outer shaft hub ata proximal end of the outer shaft, the inner shaft extending through theouter shaft hub.

Clause 2: incrementally spaced markers on a proximal portion of theinner shaft, wherein the outer shaft hub is slidable over the innershaft along the proximal portion.

Clause 3: a locking member configured to lock the outer shaft hub to aproximal portion of the inner shaft such that a position of the outershaft relative to the inner shaft is maintained when the balloon isinflated.

Clause 4: the balloon is inflatable through a lumen of the inner shaftthat contains the guidewire.

Clause 5: a stiffening wire positioned radially between the inner shaftand the outer shaft.

Clause 6: the stent comprises: a radially expandable cylindrical framecomprising struts; and protruding features carried by one or morestruts.

Clause 7: the stent is fixedly coupled to the inner shaft by an anchorportion that extends about at least a portion of the inner shaft.

Clause 8: the anchor portion is coupled to the inner shaft on a proximalside of the balloon.

Clause 9: the balloon comprises multiple segments at different axialpositions along a length of the inner shaft, the multiple segments eachbeing independently inflatable.

Clause 10: deflating the balloon; advancing the outer shaft over thestent; and removing the stent from the body lumen.

Clause 11: a connector at a proximal end of the inner shaft, theguidewire extending through the connector, the connector comprising aport in fluid communication with the balloon; and an outer shaft hub ata proximal end of the outer shaft, the inner shaft and the stabilizingwire extending through the outer shaft hub.

Clause 12: the target treatment site is a first target treatment site,the method further comprising before proximally retracting the outershaft to further unsheath the stent, repositioning the stent to a secondtarget treatment site.

Clause 13: the second length of the stent includes the first length ofthe stent.

Clause 14: before proximally retracting the outer shaft to furtherunsheath the stent, deflating the balloon and resheathing the stent.

Clause 15: before radially expanding the first length of the stent,locking the outer shaft relative to the inner shaft.

Clause 16: before radially expanding the second length of the stent,locking the outer shaft relative to the inner shaft.

A reference to an element in the singular is not intended to mean oneand only one unless specifically so stated, but rather one or more. Forexample, “a” module may refer to one or more modules. An elementproceeded by “a,” “an,” “the,” or “said” does not, without furtherconstraints, preclude the existence of additional same elements.

Headings and subheadings, if any, are used for convenience only and donot limit the invention. The word exemplary is used to mean serving asan example or illustration. To the extent that the term include, have,or the like is used, such term is intended to be inclusive in a mannersimilar to the term comprise as comprise is interpreted when employed asa transitional word in a claim. Relational terms such as first andsecond and the like may be used to distinguish one entity or action fromanother without necessarily requiring or implying any actual suchrelationship or order between such entities or actions.

Phrases such as an aspect, the aspect, another aspect, some aspects, oneor more aspects, an implementation, the implementation, anotherimplementation, some implementations, one or more implementations, anembodiment, the embodiment, another embodiment, some embodiments, one ormore embodiments, a configuration, the configuration, anotherconfiguration, some configurations, one or more configurations, thesubject technology, the disclosure, the present disclosure, othervariations thereof and alike are for convenience and do not imply that adisclosure relating to such phrase(s) is essential to the subjecttechnology or that such disclosure applies to all configurations of thesubject technology. A disclosure relating to such phrase(s) may apply toall configurations, or one or more configurations. A disclosure relatingto such phrase(s) may provide one or more examples. A phrase such as anaspect or some aspects may refer to one or more aspects and vice versa,and this applies similarly to other foregoing phrases.

A phrase “at least one of” preceding a series of items, with the terms“and” or “or” to separate any of the items, modifies the list as awhole, rather than each member of the list. The phrase “at least one of”does not require selection of at least one item; rather, the phraseallows a meaning that includes at least one of any one of the items,and/or at least one of any combination of the items, and/or at least oneof each of the items. By way of example, each of the phrases “at leastone of A, B, and C” or “at least one of A, B, or C” refers to only A,only B, or only C; any combination of A, B, and C; and/or at least oneof each of A, B, and C.

It is understood that the specific order or hierarchy of steps,operations, or processes disclosed is an illustration of exemplaryapproaches. Unless explicitly stated otherwise, it is understood thatthe specific order or hierarchy of steps, operations, or processes maybe performed in different order. Some of the steps, operations, orprocesses may be performed simultaneously. The accompanying methodclaims, if any, present elements of the various steps, operations orprocesses in a sample order, and are not meant to be limited to thespecific order or hierarchy presented. These may be performed in serial,linearly, in parallel or in different order. It should be understoodthat the described instructions, operations, and systems can generallybe integrated together in a single software/hardware product or packagedinto multiple software/hardware products.

In one aspect, a term coupled or the like may refer to being directlycoupled. In another aspect, a term coupled or the like may refer tobeing indirectly coupled.

Terms such as top, bottom, front, rear, side, horizontal, vertical, andthe like refer to an arbitrary frame of reference, rather than to theordinary gravitational frame of reference. Thus, such a term may extendupwardly, downwardly, diagonally, or horizontally in a gravitationalframe of reference.

The disclosure is provided to enable any person skilled in the art topractice the various aspects described herein. In some instances,well-known structures and components are shown in block diagram form inorder to avoid obscuring the concepts of the subject technology. Thedisclosure provides various examples of the subject technology, and thesubject technology is not limited to these examples. Variousmodifications to these aspects will be readily apparent to those skilledin the art, and the principles described herein may be applied to otheraspects.

All structural and functional equivalents to the elements of the variousaspects described throughout the disclosure that are known or later cometo be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112, sixth paragraph, unless theelement is expressly recited using the phrase “means for” or, in thecase of a method claim, the element is recited using the phrase “stepfor”.

The title, background, brief description of the drawings, abstract, anddrawings are hereby incorporated into the disclosure and are provided asillustrative examples of the disclosure, not as restrictivedescriptions. It is submitted with the understanding that they will notbe used to limit the scope or meaning of the claims. In addition, in thedetailed description, it can be seen that the description providesillustrative examples and the various features are grouped together invarious implementations for the purpose of streamlining the disclosure.The method of disclosure is not to be interpreted as reflecting anintention that the claimed subject matter requires more features thanare expressly recited in each claim. Rather, as the claims reflect,inventive subject matter lies in less than all features of a singledisclosed configuration or operation. The claims are hereby incorporatedinto the detailed description, with each claim standing on its own as aseparately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage of the claims and to encompass all legal equivalents.Notwithstanding, none of the claims are intended to embrace subjectmatter that fails to satisfy the requirements of the applicable patentlaw, nor should they be interpreted in such a way.

What is claimed is:
 1. A delivery system comprising: an outer shaft; aninner shaft slideably disposed within the outer shaft and comprising aninflatable balloon; a guidewire slideably disposed within the innershaft; and a stent disposed around the balloon and fixedly coupled tothe inner shaft.
 2. The delivery system of claim 1, further comprising:a connector at a proximal end of the inner shaft, the guidewireextending through the connector, the connector comprising a port influid communication with the balloon; and an outer shaft hub at aproximal end of the outer shaft, the inner shaft extending through theouter shaft hub.
 3. The delivery system of claim 2, further comprisingincrementally spaced markers on a proximal portion of the inner shaft,wherein the outer shaft hub is slidable over the inner shaft along theproximal portion.
 4. The delivery system of claim 2, further comprisinga locking member configured to lock the outer shaft hub to a proximalportion of the inner shaft such that a position of the outer shaftrelative to the inner shaft is maintained when the balloon is inflated.5. The delivery system of claim 1, wherein the balloon is inflatablethrough a lumen of the inner shaft that contains the guidewire.
 6. Thedelivery system of claim 1, further comprising a stiffening wirepositioned radially between the inner shaft and the outer shaft.
 7. Thedelivery system of claim 1, wherein the stent comprises: a radiallyexpandable cylindrical frame comprising struts; and protruding featurescarried by one or more struts.
 8. The delivery system of claim 1,wherein the stent is fixedly coupled to the inner shaft by an anchorportion that extends about at least a portion of the inner shaft.
 9. Thedelivery system of claim 8, wherein the anchor portion is coupled to theinner shaft on a proximal side of the balloon.
 10. The delivery systemof claim 1, wherein the balloon comprises multiple segments at differentaxial positions along a length of the inner shaft, the multiple segmentseach being independently inflatable.
 11. A delivery system comprising:an outer shaft; an inner shaft slideably disposed within the outer shaftand comprising an inflatable balloon on a distal portion of the innershaft; a guidewire slideably disposed within the inner shaft; and astent slideably disposed within the outer shaft and on a proximalportion of the inner shaft that is proximal to the balloon, the stentbeing connected to a stabilizing wire that is slideably disposed withinthe outer shaft.
 12. The delivery system of claim 11, furthercomprising: a connector at a proximal end of the inner shaft, theguidewire extending through the connector, the connector comprising aport in fluid communication with the balloon; and an outer shaft hub ata proximal end of the outer shaft, the inner shaft and the stabilizingwire extending through the outer shaft hub.
 13. The delivery system ofclaim 11, wherein the balloon is inflatable through a lumen of the innershaft that contains the guidewire.
 14. The delivery system of claim 11,wherein the stent comprises: a radially expandable cylindrical framecomprising struts; and protruding features carried by one or morestruts.
 15. The delivery system of claim 11, wherein the stent isfixedly coupled to the stabilizing wire by an anchor portion thatextends about at least a portion of the stabilizing wire.
 16. A deliverysystem comprising: an outer shaft; an inner shaft slideably disposedwithin the outer shaft and comprising an inflatable balloon on aproximal portion of the inner shaft; a guidewire slideably disposedwithin the inner shaft; and a stent slideably disposed within the outershaft and on a distal portion of the inner shaft that is distal to theballoon, the stent being connected to a stabilizing wire that isslideably disposed within the outer shaft.
 17. The delivery system ofclaim 16, further comprising: a connector at a proximal end of the innershaft, the guidewire extending through the connector, the connectorcomprising a port in fluid communication with the balloon; and an outershaft hub at a proximal end of the outer shaft, the inner shaft and thestabilizing wire extending through the outer shaft hub.
 18. The deliverysystem of claim 16, wherein the balloon is inflatable through a lumen ofthe inner shaft that contains the guidewire.
 19. The delivery system ofclaim 16, wherein the stent comprises: a radially expandable cylindricalframe comprising struts; and protruding features carried by one or morestruts.
 20. The delivery system of claim 16, wherein the stent isfixedly coupled to the stabilizing wire by an anchor portion thatextends about at least a portion of the stabilizing wire.